Chronic Pulmonary Aspergillosis
Conditions
Interventions
Trough concentrations of isavuconazole in plasma for research.
Sponsors
Izumikawa Koichi
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1 Patients who have personally provided written, informed consent to participate in the study. 2 Japanese men or women aged 18 years or older at the time of informed consent. 3 Patients on initial treatment for CPA or patients with relapsed CPA ([proven] or [probable]). 4 Patients changing from treatment with other drugs (patients who are intolerant to other drugs or whose symptoms and imaging findings of CPA are not improving)([proven] or [probable]). 5 Patients for whom the initiation of ISAV treatment has been decided by the investigator or sub-investigator.
Exclusion criteria
Exclusion criteria: 1 Patients for whom ISAV is contraindicated in accordance with the Japanese package insert. 2 Patients with congenital short QT syndrome. 3 Patients with severe hepatic impairment (Child-Pugh C). 4 Female patients who are pregnant or nursing. 5 Patients who are unlikely to survive until study completion. 6 Patients whose personal circumstances are not conducive to long-term treatment. 7 Patients with a causative fungus other than Aspergillus species. 8 Patients who have been treated with ISAV previously and had failed to respond or were intolerant to the treatment. 9 Patients who have received ISAV within the last 3 months. 10 Patients participating in an ongoing interventional clinical trial. 11 Patients who have participated in the study in the past. 12 Any other patients deemed unsuitable to participate in the study by the investigator or sub-investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| -Adverse event incidences -Adverse reaction incidences -Percentages of patients able to continue treatment (by period) -Percentages of patients who switched treatment (by cause) -Percentages of patients who discontinued treatment (by cause) -Time profiles of laboratory test results | — |
Secondary
| Measure | Time frame |
|---|---|
| -Response rate with respect to overall outcome effect based on the results of assessment by the investigator or sub-investigator -Response rates with respect to the effect on clinical symptoms and the effect on diagnostic imaging based on the results of assessment by the investigator or sub-investigator and the disappearance rate with respect to mycological effect -All-cause mortality | — |
Contacts
Public ContactTakahiro Takazono
Nagasaki University Granduate School of Biomedical Sciences
Outcome results
None listed